Thoratec

BACKGROUND: Optimal anticoagulation strategy remains uncertain in patients with heparin-induced thrombocytopenia (HIT) and undergoing left ventricular assist device (LVAD) implantation. We describe our protocol of abciximab and heparin in these patients. METHODS: Our protocol is to administer abciximab, 0.25 mg/kg loading dose, followed by continuous infusion of 0.125 μg · kg(-1) · min(-1) throughout cardiopulmonary bypass. Full-dose heparin is then given with subsequent additional doses to maintain an activated clotting time of 400 seconds or longer...

This study aimed to compare von Willebrand factor (vWF) levels, ristocetin cofactor levels, platelet counts, aortic valve movements, and right heart failure (RHF) as risk factors of gastrointestinal (GI) bleeding in patients with continuous flow left ventricular assist device (cf-LVAD). In a single centre, 90 patients (mean age 52.0 ± 10.5 years), of which 59 were male and 31 were female, had cf-LVAD implantation from October 2010 to November 2012. Seventy-six (84.4%) patients had HeartWare (Medtronic, Mounds View, MN) and 14 (15...

Patients with Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) levels 1-2 who either have or are at risk for right ventricular failure face significant morbidity and mortality after continuous flow left ventricular assist device (CF-LVAD) implantation. Currently, the options for biventricular support are limited the Total Artificial Heart (TAH; CardioWest, Syncardia, Tuscon, AZ) or biventricular assist device (BiVAD), which uses bulky extracorporeal or implantable displacement pumps...

CorMatrix is an organic extracellular matrix (ECM) derived from porcine small intestine submucosa and is used for pericardial closure and cardiac tissue repair. During explantation of a HeartMate II (Thoratec Corp, Pleasanton, CA) left ventricular assist device (LVAD) because of infection, CorMatrix was used to repair the left ventricular apex and aorta. Three months later, a HeartWare HVAD (HeartWare International, Inc, Framingham, MA) was implanted for recurrent heart failure. Excised apical CorMatrix samples showed cardiac tissue remodeling with viable cardiomyoblasts similar to native myocardium...

BACKGROUND: The HeartMate II (St. Jude Medical, Inc, St. Paul, MN [previously Thoratec]) left ventricular assist device (LVAD) exchange has traditionally involved a redo sternotomy. Alternate minimally invasive subcostal approaches have the advantage of avoiding sternal reentry, excessive bleeding, and prolonged recovery. METHODS: This retrospective review included patients who underwent an exchange from May 2009 to March 2016. The patients were divided into three cohorts: (1) redo sternotomy, (2) subcostal approach involving cardiopulmonary bypass (CPB) (ON-CPB SC), and (3) subcostal approach off the CPB pump (OFF-CPB SC)...

BACKGROUND: Optimal timing of heart transplantation in patients supported with second-generation left ventricular assist devices (LVADs) is unknown. Despite this, patients with LVADs continue to receive priority on the heart transplant waiting list. Our objective was to determine the optimal timing of transplantation for patients bridged with continuous-flow LVADs. METHODS: A total of 301 HeartMate II LVADs (Thoratec Corp, Pleasanton, CA) were implanted in 285 patients from October 2004 to June 2013, and 86 patients underwent transplantation through the end of follow-up...

OBJECTIVE: To determine whether the ratio of peak systolic-to-nadir diastolic velocity (S/D ratio) measured using Doppler at the left ventricular assist device (LVAD) inflow and outflow cannulae is associated with pump thrombosis and to determine whether there is an absolute decrease in the diastolic cannula velocities in LVAD thrombosis. DESIGN: Retrospective chart review. SETTING: University hospital. PARTICIPANTS: Patients who underwent LVAD exchange...

BACKGROUND: There are minimal circulatory support options for patients with a failing Fontan. The Heartmate II (HMII) left ventricular assist device (Thoratec, Bedford, MA) in its packaged state cannot augment caval/pulmonary arterial blood flow. AIM: We hypothesized that a modified HMII pump could augment caval and pulmonary arterial blood flow. METHODS: A bifurcated ringed Gore-Tex graft (W. L. Gore & Associates, Flagstaff, AZ) was sewn to the HMII inflow, and the outflow graft transected and tapered from 16 mm to 8 mm in diameter...

The use of continuous-flow left ventricular assist devices (CF-LVADs) has revolutionized the landscape of mechanical circulatory support for patients with heart failure. Clinical trials are already testing the next generation of CF-LVADs. In this study, our objective was to review our long-term experience with the current generation of CF-LVADs, specifically, the HeartMate (HM) II (Thoratec Corp, Pleasanton, CA). In this single-center retrospective analysis, we evaluated the records of 278 consecutive patients who underwent a total of 302 HM II placements from June 2005 through June 2014...

With more than 60 years of continuous development and improvement, a variety of temporary mechanical circulatory support (MCS) devices and implantation strategies exist, each with unique advantages and disadvantages. A thorough understanding of each available device is essential for optimizing patient outcomes in a fiscally responsible manner. In this state of the art review we examine the entire range of commonly available peripheral and centrally cannulated temporary MCS devices, including intra-aortic balloon pumps, the Impella (Abiomed, Danvers, MA) family of microaxial pumps, the TandemHeart (CardiacAssist Inc, Pittsburg, PA) pump and percutaneous cannulas, centrally cannulated centrifugal pumps such as the CentriMag (Thoratec Corp, Pleasanton, CA/St Jude Medical, St Paul, MN/Abbott Laboratories, Abbott Park, IL) and Rotaflow (Maquet Holding BV & Co KG, Rastatt Germany), and extracorporeal membrane oxygenation...

Continuous flow ventricular assist devices (cfVADs) provide a life-saving therapy for severe heart failure. However, in recent years, the incidence of device-related thrombosis (resulting in stroke, device-exchange surgery or premature death) has been increasing dramatically, which has alarmed both the medical community and the FDA. The objective of this study was to gain improved understanding of the initiation and progression of thrombosis in one of the most commonly used cfVADs, the Thoratec HeartMate II...

Background Left ventricular assist devices (LVADs) have revolutionized the treatment of patients with end-stage heart failure. These devices are replaced when pump complications arise if heart transplant is not possible. We present our experience with HeartMate II (HMII (Thoratec, Plesanton, California, United States)) LVAD pump exchange. Materials and Methods We retrospectively reviewed all cases that required pump exchange due to LVAD complication from November 2011 until June 2016 at a single high-volume institution...

BACKGROUND: Recommended structured clinical practices including implant technique, anti-coagulation strategy, and pump speed management (PREVENT [PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management] recommendations) were developed to address risk of early (<3 months) pump thrombosis (PT) risk with HeartMate II (HMII; St. Jude Medical, Inc. [Thoratec Corporation], Pleasanton, CA). We prospectively assessed the HMII PT rate in the current era when participating centers adhered to the PREVENT recommendations...

A 62-year-old man with coronary artery disease and ischemic cardiomyopathy after coronary artery bypass grafting and insertion of a HeartMate II (Thoratec, Pleasanton, CA) left ventricular assist device (LVAD) presented with spontaneous incisional bleeding and an ascending aortic pseudoaneurysm. Aortic angiography revealed an anomalous connection between the pseudoaneurysm and the LVAD conduit. We were able to partially embolize the tract with standard techniques, but the patient returned with repeated bleeding...

BACKGROUND: Patients with advanced heart failure (HF) are predisposed to ventricular arrhythmias (VAs), particularly following implantation of a left ventricular assist device (LVAD). There is minimal evidence for appropriate management strategies. OBJECTIVES: This study aimed to compare the burden of VA and response to ablation performed either before or following LVAD implantation. METHODS: We created a retrospective cohort of patients who underwent both VA ablation and Heart Mate II (Thoratec, Pleasanton, CA, USA) LVAD implantation at Mayo Clinic (Rochester, MN, USA)...

BACKGROUND: Early right-sided heart failure (RHF) after left ventricular assist device (LVAD) implantation is associated with increased mortality, but little is known about patients who develop late RHF (LRHF). We evaluated the incidence, risk factors, and clinical impact of LRHF in patients supported by axial-flow LVADs. METHODS: Data were analyzed from 537 patients enrolled in the HeartMate II (HM II; Thoratec/St. Jude) destination therapy clinical trial. LRHF was defined as the development of clinical RHF accompanied by the need for inotropic support occurring more than 30 days after discharge from the index LVAD implant hospitalization...

BACKGROUND: Supraphysiologic shear stress from continuous-flow left ventricular assist devices (LVADs) accelerates von Willebrand factor (vWF) degradation and predisposes patients to nonsurgical bleeding. It is unknown whether unique design characteristics of LVADs differentially affect vWF degradation. We tested the hypothesis that the centrifugal-flow EVAHEART (Evaheart, Houston, TX) left ventricular assist system (LVAS), which was designed to minimize shear stress (low operational revolutions per minute [rpm], larger flow gaps, low shear stress, flat H-Q curve), reduced vWF degradation versus the axial-flow HeartMate II (Thoratec, Pleasanton, CA) LVAD...

BACKGROUND: Heart transplantation remains the definitive therapy for patients with advanced heart failure; however, owing to limited donor organ availability and long wait times, continuous-flow left ventricular assist devices (LVADs) have become standard therapy. METHODS: This review summarizes the history, progression, function, and basic management of LVADs. Additionally, we provide some clinical pearls and important caveats for managing this unique patient population...

BACKGROUND: Indications for concomitant intervention for mitral regurgitation (MR) during left ventricular assist device (LVAD) implantation remain controversial. The objective of this study was to determine the impact of the surgical correction of MR during LVAD implantation. METHODS: From July 2008 to December 2014, 164 patients with significant preoperative MR underwent LVAD (HeartMate II; Thoratec, Pleasanton, CA) implantation. The MR resolved after LVAD implantation in 110 of 164 patients (67...

BACKGROUND: Circulatory failure necessitating cardiac transplantation will ultimately develop in many patients with functional single-ventricle physiology. Interest in the use of mechanical circulatory support (MCS) in this population is growing. METHODS: This was a retrospective case series of patients with functional single-ventricle physiology who underwent MCS with a ventricular assist device or a total artificial heart as a bridge to cardiac transplantation between January 2006 and December 2014...